Sr. Process Controls & Validation Engineer
About The Position
At Regeneron, we use science and innovation to develop life-changing medicines for people with serious diseases. We’re seeking a Process Controls & Validation Engineer with a strong background in cGMP validation, who can develop sound process control strategy, bring structure to ambiguous technical problems, and confidently lead and influence discussions across Manufacturing, Quality and Regulatory teams. Process Sciences is a technical services department that deals with a range of scientific, technical, engineering and mathematical needs from the laboratory to the manufacturing floor. This role provides technical support to our bulk manufacturing, quality and CMC Regulatory for manufacturing processes from technology transfer and/or design transfer to post-commercial lifecycle management activities.
Requirements
- BS in Engineering; chemical engineering or biomedical engineering preferred
- Process Controls & Validation Engineer: 2+ years of experience
- Sr. Process Controls & Validation Engineer: 5+ years of experience
- Level will be determined based on experience
- Experience with process validation, tech transfer and scale up for drug substance
Responsibilities
- Leads and provides hands-on support for cGMP process validation (Stage 1–3), technology transfer, design transfer, scale-up, and process control strategy development, from protocol authoring through execution and lifecycle management—translating ambiguous, early-stage problems into clear, actionable plans with limited direction
- Evaluates product/process risk and applies engineering judgment to resolve gaps and uncertainty as processes move from development to at-scale manufacturing
- Analyzes data across the process lifecycle—from development through characterization and manufacturing history—using statistics and engineering principles to inform control strategy, validation decisions, and identify critical process parameters, control limits, and monitoring plans
- Leads and influences cross-functional discussions with Manufacturing, Quality Control, Quality Assurance, and CMC Regulatory, driving alignment and decisions on process lifecycle management, and effectively navigating differing stakeholder priorities
- Authors protocols, reports, and technical documents grounded in available process/product knowledge; ensures SOPs, policies, and validation plans align with industry/regulatory expectations (e.g., ICH); supports audits/inspections and CMC sections of regulatory submissions as needed
- Provides hands-on support for laboratory and manufacturing-scale studies, working effectively in a team-oriented environment
Benefits
- annual bonuses or other incentive plans
- equity awards
- pension or retirement benefits
- 401(k) company match
- health and wellness programs
- fitness centers
- insurance benefits (e.g. medical, dental, vision, life and disability)
- paid time off
- family support benefits
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
